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Serving leading biopharmaceutical companies globally:

Novartis
UBS
Healthtrust
Baxter
Daiichi Sankyo
Express Scripts
Johnson and Johnson
Fuji
US Army
US Department of Justice

Generated: January 20, 2018

DrugPatentWatch Database Preview

QSYMIA Drug Profile

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When do Qsymia patents expire, and when can generic versions of Qsymia launch?

Qsymia is a drug marketed by Vivus and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-one patent family members in twenty-six countries.

The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.

US Patents and Regulatory Information for QSYMIA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-004 Jul 17, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-003 Jul 17, 2012 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-003 Jul 17, 2012 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-003 Jul 17, 2012 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-003 Jul 17, 2012 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-001 Jul 17, 2012 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-002 Jul 17, 2012 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-003 Jul 17, 2012 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-004 Jul 17, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-001 Jul 17, 2012 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for QSYMIA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-001 Jul 17, 2012 ➤ Subscribe ➤ Subscribe
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-002 Jul 17, 2012 ➤ Subscribe ➤ Subscribe
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-003 Jul 17, 2012 ➤ Subscribe ➤ Subscribe
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-004 Jul 17, 2012 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for QSYMIA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release Capsules 3.75 mg/23 mg, 7.5 mg/46 mg, 11.25 mg/69 mg, 15 mg/92 mg ➤ Subscribe 7/18/2013

Non-Orange Book US Patents for QSYMIA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,802,636 Combination therapy for treatment of sleep apnea ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for QSYMIA

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Serving leading biopharmaceutical companies globally:

Novartis
Covington
Chinese Patent Office
UBS
Chubb
Citi
Cantor Fitzgerald
Farmers Insurance
Fish and Richardson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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